SIGA will seek FDA approval for treatment of monkeypox when data becomes available

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Monkeypox outbreak sent drugmaker stocks

SIGA Technologies

up more than 200% this year, though the company’s antiviral monkeypox remains hard to get in the U.S.

In an interview on Friday,

SIGA

(ticker: SIGA) leaders said Barrons they planned to apply to the Food and Drug Administration for approval or clearance of their drug TPOXX as a treatment for monkeypox as soon as new efficacy data became available.

It’s unclear how long that might take. On Thursday, the United States declared the monkeypox outbreak a public health emergency, which would allow the FDA to issue emergency use authorizations for monkeypox therapeutics. On a media call, however, FDA Commissioner Dr. Robert Califf said TPOXX still needs to be studied closely.

“We think it’s going to be effective against monkeypox, but we don’t have proof of that yet,” Califf said.

On Friday, SIGA Chief Scientific Officer Dennis Hruby said he was confident the drug is effective as a treatment for monkeypox. “I have no doubt it will work,” Hruby said.

SIGA on Thursday night reported second-quarter revenue of $16.7 million and diluted earnings of three cents per share. SIGA shares jumped around 20% on Friday to $23.30.

There are just over 7,000 confirmed cases of monkeypox in the United States and nearly 27,000 worldwide. The explosion of cases of a virus that was previously only endemic in parts of Africa could significantly increase demand for SIGA’s drugs.

SIGA’s operations, until this spring, were entirely focused on selling TPOXX in government stockpiles, largely for use in the event of a smallpox outbreak. The FDA approved TPOXX as a treatment for smallpox in 2018 under a rule that allows approval of drugs based on animal data, when human trials are not ethical or feasible.

Although SIGA has conducted safety and pharmacokinetic studies of TPOXX in humans, it has only tested the drug’s efficacy in monkeys infected with monkeypox and then treated with TPOXX. SIGA originally sought FDA approval for TPOXX as both a treatment for smallpox and monkeypox, but only received agency approval for the smallpox indication. Regulators in the European Union and the United Kingdom have both approved the drug to treat monkeypox based on the same monkey data.

Now a number of randomized controlled trials of TPOXX in patients with monkeypox are expected to begin soon, including in the UK and the US. SIGA does not conduct the trials, but supplies them with drugs and placebos.

“It will depend on the number of patients with monkeypox, but as soon as we have data from these trials, whether it is interim analyses, final data, we will certainly submit them to the FDA and we will make sure to trying to expedite approval, either through an EUA or formal approval,” said company CEO Phil Gomez. Barrons.

Still, Gomez said access to the drug could be expanded ahead of trial data. “We are very much in favor of randomized controlled trials, and we should separate that from when an approval process or a change in policy allows greater access to the drug,” he said.

In the United States, patients are currently accessing TPOXX through what is called an expanded access trial. The FDA and the Centers for Disease Control and Prevention have relaxed regulations in recent weeks, although registration is still taking time.

SIGA executives say they could ramp up manufacturing to half a million doses of TPOXX per year. The company does not have its own manufacturing facilities, but instead relies on a number of contract manufacturing facilities.

“We don’t have a factory working full-time on TPOXX,” Gomez said. “The highest theoretical production depends not only on the capacity they have, but also on the possibility of accessing it and when we have access to it.”

Gomez wouldn’t disclose the exact price the United States pays per treatment, but says it’s around $300 to $400.

SIGA began delivering doses of TPOXX to US stock in 2013 and had delivered 1.7 million courses in the US by 2017. Doses from stock began to expire in 2020 and SIGA delivered 363,000 courses to United States to replenish the stock that year, and 363,000 more in 2021.

Gomez said SIGA planned to ramp up production this year even before the monkeypox outbreak. Along with the 363,000 expired doses in US stock that the company had planned to replace, the company also received European approval for the drug shortly before the outbreak began.

While only the United States and Canada stockpiled TPOXX before the outbreak, more countries have sought in recent months to acquire doses. SIGA says it received about $60 million in orders this year from outside the United States, from 10 separate jurisdictions.

Gomez says the outbreak could change his company’s long-term drug market.

“Before the monkeypox outbreak, only the United States and Canada really had a stockpile,” he said. “It reminds us that it’s important for governments to think about these outbreaks, because after an outbreak it’s very difficult to get access to these products, given time and capacity.”

Write to Josh Nathan-Kazis at [email protected]

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